Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001260314
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
24/09/2026
Date registered
Help: Date registered
19/10/2026
Date last updated
Help: Date last updated
19/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
19/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Animal-Assisted Therapy on Acute Pain and Wellbeing in Trauma Patients
Scientific title
Effects of Animal-Assisted Therapy on Acute Pain and Wellbeing in Trauma Patients
Additional trial identifiers [1] 318518 0
nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Pain 343700 0
Mental health 343701 0
Condition category
Condition code
Injuries and Accidents 339818 339818 0 0
Other injuries and accidents
Mental Health 339897 339897 0 0
Anxiety
Mental Health 339898 339898 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The Acute Pain Service consists of four acute pain consultants (physicians, anaesthetists and chronic pain specialists) who rotate on a weekly basis, typically supported by two pain nurses and a trainee. A standard pain round visit involves pain assessment, chart review, optimisation of pain medication, and patient education. This follows a standardised process, with visit duration individualised to each patient but typically ranging from 10 to 15 minutes.

Once a patient is enrolled, a baseline questionnaire will be filled and randomisation will occur. Participants randomised to a pain team visit with a dog will be introduced to the animal and handler. After this the pain team will take over and complete the visit with the animal still present. The animal and handler may stay a little longer afterwords, depending on patient needs, ward business.

The animal handler will facilitate the participant-animal interaction, positioning the therapy dog in a manner that is comfortable for the participant. The nature of the interaction will be guided by the participant's preferences. The participant may converse about the therapy dog or their own pets, or may choose to pat and directly interact with the dog. The animal will be supervised at all times, in accordance with Te Toka Tumai policy. A therapy dog visit will last approximately 10-20 minutes, consistent with standard practice at our institution.

This is a once only interaction due to the limited availablity of therapy animals.

Participants randomised to pain team review only (standard care at our hospital) will not be visited by a dog at all.

Each participant will answer the same brief questionnaire 20 min after pain team review.

Each questionnaire is expected to take 5min to complete. An additional open ended question regarding the experience of being visited by a dog will be asked of participants randomised to dog visit..

The first 30 participants will be included in the pilot phase of this study. They will be asked additional question about their experience of being approached for the study and asked for feedback.

Both groups will receive standard care which is a pain team review. 50% of patients will aslo receive a pet visit. Recruitment, randomisation and data collection is expected to be completed on the day of recruitment.
Intervention code [1] 335418 0
Rehabilitation
Intervention code [2] 335530 0
Treatment: Other
Description of the comparator or control
The comparator is a visit by the acute pain service which consists of four consultants (physicians, anaesthetists and chronic pain specialists) who rotate on a weekly basis, typically supported by two pain nurses and a trainee.

A standard pain round visit involves pain assessment, chart review, optimisation of pain medication, and patient education. This follows a standardised process, with visit duration individualised to each patient but typically ranging from 10 to 15 minutes.

The pain specialists will be notified if their patient has agreed to participate. The researcher will facilitate study enrolment, questionnaire administration, data collection without interfering with the delivery of care to that participant and without affecting the work flow of the ward or pain round.

Patients will continue to be visited by a pain specialists as needed during their stay, hence their care will not be altered in any way. As the study enrolment, intervention and data collections completes in a single day, only the pain team visit on that day will be included in the study.
Control group
Active

Outcomes
Primary outcome [1] 346991 0
Pain score variation (pain score change before and after intervention) on 11 point NRS scale when pet therapy is combined with acute pain round vs a pain round alone (standard care).
Timepoint [1] 346991 0
Immediately before and approximately 20 minutes after the pain team visit.
Secondary outcome [1] 468507 0
Effects on depression measured on 11 point scale (numeric and descriptive) when pet therapy (with acute pain round) visit is compared to acute pain visit alone.
Timepoint [1] 468507 0
Immediately before and approximately 20 minutes after the pain team visit.
Secondary outcome [2] 468816 0
Effects on anxiety measured on 11 point scale (numeric and descriptive) when pet therapy (with acute pain round) visit is compared to acute pain visit alone.
Timepoint [2] 468816 0
Immediately before and approximately 20 minutes after the pain team visit.
Secondary outcome [3] 468817 0
Effects on overall wellbeing measured on 11 point scale (numeric and descriptive) when pet therapy (with acute pain round) visit is compared to acute pain visit alone.
Timepoint [3] 468817 0
Immediately before and approximately 20 minutes after the pain team visit.

Eligibility
Key inclusion criteria
All trauma patients admitted to Auckland City Hospital who are able to consent with or without interpreter and willing to participate with or without pet visit
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Refusal to participate
Communication barrier where interpretation services are not available
Infectious risk (patient in isolation)
Patients in intensive care, high dependency unit or in the emergency department

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be randomised to standard care or standard care plus pet therapy on days when pet is available. Enrolled patients will be stratified based on baseline pain score. Stratification will ensure even baseline pain score prior to randomisation.

Randomisation will be done by a statistician and then imported into REDCap. Randomisation allocation will be available as soon as patients have consented, also via REDCap.

Randomisation allocation will be revealed to researcher at a push of a buton via a portable tablet and ony after consent is completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in a 1:1 allocation ratio to either the intervention group (therapy dog visit) or the control group (no therapy dog visit). Group assignments will be generated after participant enrolment and after entering the baseline pain score. This score will be used to stratify patients prior to randomisation. This will ensure an even distribution of baseline pain severity between the two groups. A cut off score of 6 will be used to divide low vs high pain score patients. A score of less or equal to 6 indicates low-moderate pain whereas a score of 7 and above indicates severe pain
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Quantitative data analysis will be conducted using R version 4.3.2 or later. We will use a two-way independent ANOVA test to compare mean difference in change scores before and after visiting with the therapy dog (i.e., post-treatment measure minus pre-treatment measure produced a change score for each participant).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2026
Actual
Date of last participant enrolment
Anticipated
1/12/2028
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment outside Australia
Country [1] 28590 0
New Zealand
State/province [1] 28590 0
Auckland

Funding & Sponsors
Funding source category [1] 323101 0
Hospital
Name [1] 323101 0
Research Unit Auckland City Hospital
Country [1] 323101 0
New Zealand
Funding source category [2] 323200 0
Charities/Societies/Foundations
Name [2] 323200 0
Auckland city Hospital Pet therapy funded by Auckland Hospital foundation
Country [2] 323200 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 326048 0
Other Collaborative groups
Name [1] 326048 0
JAFA - Joint Anaesthesia Faculty Auckland
Address [1] 326048 0
Country [1] 326048 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321498 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 321498 0
Ethics committee country [1] 321498 0
New Zealand
Date submitted for ethics approval [1] 321498 0
22/07/2026
Approval date [1] 321498 0
29/07/2026
Ethics approval number [1] 321498 0
2026 FULL 25367

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 153902 0
Dr Lora Pencheva
Address 153902 0
Auckland City Hospital, 2 Park road, Grafton, Auckland 1023
Country 153902 0
New Zealand
Phone 153902 0
+64 210405823
Fax 153902 0
Email 153902 0
[email protected]
Contact person for public queries
Name 153903 0
Dr Lora Pencheva
Address 153903 0
Auckland City Hospital, 2 Park road, Grafton, Auckland 1023
Country 153903 0
New Zealand
Phone 153903 0
+64 210405823
Fax 153903 0
Email 153903 0
[email protected]
Contact person for scientific queries
Name 153904 0
Dr Lora Pencheva
Address 153904 0
Auckland City Hospital, 2 Park road, Grafton, Auckland 1023
Country 153904 0
New Zealand
Phone 153904 0
+64 210405823
Fax 153904 0
Email 153904 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    HDEC Approval Letter.pdf
Study protocol    Pets on pain rounds V2.31.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.